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News & Press: Position Statements

Acceptable criteria for regulated analytes for HbA1c

Wednesday, March 6, 2019   (1 Comments)
Posted by: Alice Mourey
With the current College of American Pathologists (CAP) proficiency testing requirements, the HbA1c results (in DCCT/NGSP % units or IFCC mmol/mol units) should be within ± 6%, i.e. a measured value of 7.0% DCCT/NGSP should be within the range 6.58% to 7.42% and 53 mmol/mol should be within 50 and 56. The Clinical Laboratory Improvement Amendments (CLIA) proposes to change the acceptable criteria for regulated analytes to ± 10% for HbA1c.


This change would totally erase the progress in quality improvement in measuring HbA1c that has served the diabetes community so well over the past few years. ISPAD therefore urges CMS to readdress this matter and change the criteria for acceptable performance of HbA1c to ± 5%.


Over half a million children and adolescents around the world depend upon a correct decision in this matter to reduce their risk of long-term complications.


Click here to read the full statement from ISPAD.



Posted Saturday, August 10, 2019
Thank you for the clarification

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